SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
___________________
Date of Report (Date of earliest event reported) October 31, 1997
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-10822 25-1229323
(State of other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
On October 31, 1997, Biocontrol Technology, Inc.
(NASDAQ:BICO) released the attached information on
their Webbsite.
Item 6. Resignation of Registrant's Directors.
Not Applicable
Item 7. Financial Statement, Pro Forma Financial Information
and Exhibits.
(a) Financial Statements and Businesses Acquired - Not
Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits-Press Release
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act
of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned hereunto duly authorized.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper,
Fred E. Cooper, CEO
DATED: October 31, 1997
The Pittsburgh Post Gazette has supplied Biocontrol with
questions whose answers are intended for the basis of an article.
In the past, the Company stopped dignifying the paper and its
reporter, Patricia Sabatini, with a response because early
attempts to do so resulted in Company answers that were twisted
and tweaked to support the less-than-reputable sources of
disgruntled former employees. However, the Company feels that it
must address this most recent attack on the Company and some of
its employees as highly misrepresentative allegations are made.
Once again, Biocontrol believes that the sources are revenge-
seeking former employees.
The questions and Biocontrol's answers follow, together with a
letter (printed here at the end) sent to Sabatini from Biocontrol
attorney, Thomas J. Miller of the Houston Harbaugh firm.
1). Numerous company insiders say the Diasensor doesn't work,
and they've provided the Post Gazette with copies of internal
documents to back up their claims. How do you respond?
A claim that the Diasensor does not work is preposterous and
could only be made by people who are trying to cause problems for
the company but who do not understand the documents and data they
are reading. Biocontrol suspects that the "insiders" are once
again disgruntled former employees who feel they have a platform
on which to cause problems because you and your paper continue to
give them credence. Since, despite our request, you will not
identify the documents, we cannot comment on them specifically.
2). Numerous company insiders say Biocontrol hasn't shown the
Diasensor works on even one diabetic patient. How do you
respond?
Again, such a claim could only have been made by people who do
not understand what they are reading, but are looking to cause a
problem for the Company. Those patients who have tested on the
sensor would certainly take issue with such a statement. The
sensor has been tested, and continues to be tested, on many
patients and the results compared to the industry standard for
accuracy, the Yellow Springs Instrument. Such data has been
formally submitted to the FDA.
3). Mark Arnold, a professor of chemistry at the University of
Iowa, says he's studied scientific papers written by Biocontrol's
Ralf Marbach, which he says fail to prove researchers were ever
able to measure glucose. He says any results that appear to
correlate with actual glucose levels happened by chance. How do
you respond?
Dr.Arnold refers to research carried out in the time period from
1988 to 1993 by an interdisciplinary team of researchers at the
Institute for Spectrochemistry and Applied Spectroscopy and the
Diabetes Research Institute, both located in Germany. The work
was funded by the German Research Foundation and the key
publications resulting from this rather unique research effort
were authored by Dr. H.M. Heise (ISAS, project leader), Dr. Th.
Koschinsky (Head of Clinical Dept., DRI), Dr. F.A. Gries
(Director, DRI),and Ralf Marbach (ISAS, Ph.D. student at the
time). Dr. Marbach joined Biocontrol after the completion of
this research project.
The particular paper Arnold is referring to is Noninvasive Blood
Glucose Assay by Near-Infrared Diffuse Reflectance Spectroscopy
of the Human Inner Lip, Applied Spectroscopy 47, 875 (1993). In
this paper, the results from three different experiments are
described. Dr. Arnold's critique is targeted at the first
experiment, which was a two-day, single patient, oral-glucose
tolerance test experiment, and which - as Dr. Arnold correctly
points out - does not have the statistical power to prove genuine
correlation, because of the potential danger of chance
correlations. This first experiment, however, was only a
preliminary milestone within the research project. Genuine
correlation was proven in the second and third experiments which
predicted glucose for the case of a randomly selected population
of 133 different patients at DRI, and for the case of a single
diabetic patient who was actively following a computer-generated
random glucose time profile over several weeks.
It is surprising to see Dr. Arnold overlook the main results of
the German research effort which, by the way, are still the only
randomized, noninvasive glucose results published by academia so
far (as of 30 Oct 97).
Also important to note is the fact that Biocontrol believes that
Mark Arnold is affiliated with a competitor which has been unable
to measure glucose.
4). Has Biocontrol proven the Diasensor effectively measures
glucose? How? On whom?
Yes. The fact that the Diasensor measures glucose using infrared
light transflected from the patient's arm has been proven during
several clinical trials. The results of such trials have been
given to the FDA but are proprietary and confidential, including
the participants' names. The identity of patients is kept
strictly confidential to protect their privacy from certain
invasion by the media; however, several such patients were in
attendance at the February 26, 1996 panel review.
5). Company insiders have told to the Post-Gazette that
Biocontrol doctored and manipulated clinical test results
submitted to the Food and Drug Administration to try to make the
test results on the Diasensor appear more favorable. Do you have
a comment?
Biocontrol has never doctored and manipulated clinical test
results. If such an allegation were true, would we not have
already received FDA approval with data doctored exactly to their
requirements? If that allegation were true, wouldn't we have
doctored the data to a point where we would not have had to
endure all of the discussions and questions of the last four
years?
6). Several Biocontrol employees say they witnessed Biocontrol's
Patrick Cooper applying white-out to error grid charts submitted
to the FDA to cover up glucose readings in the "D" and "E" danger
zones. Do you have a comment?
Again, Biocontrol has never doctored clinical test results. In
the incidents referred to, white-out was not used to "cover up"
bad results but was used rather to correct computational errors
that would have caused the actual correct data to be
misrepresented. Such errors occurred due to missapplications of
the computer program used to analyze the data. Dishonest deeds
are usually done in private, not in full view of witnesses. The
accusations that a respected and honest man would engage in such
actions is not only offensive, but may also give rise to legal
action by the Company and/or the individuals involved.
7). Company insiders say Biocontrol rigged public demonstrations
of the Diasensor to make it appear the machine was working.
They've provided details on how the Diasensor was set up
beforehand to guarantee the demonstrations would appear
successful. Do you have a comment?
This accusation is not only false, but also absurd. In all
demonstrations of tests that were performed on functioning
devices and witnessed by various individuals outside of the
company, actual patient algorithms for measuring glucose were
used. Any adjustments to the machine were done merely to update
to the most current patient algorithm. If, as alleged, the
company had rigged demonstrations of the Diasensor to "guarantee
the demonstrations would appear successful," then how do you
account for the failure of the Diasensor to read during one of
two tests performed at the company's shareholders' meeting of
2/24/97?
8.) Biocontrol has said it hired a private detective, Jack Nard,
more than a year ago to investigate the company's mistreatment by
the FDA. What has the investigation uncovered?
Jack Nard is a consultant for Biocontrol, not a private
investigator, who has been conducting an investigation of the FDA
February 26, 1996 panel review of the Diasensor. Mr. Nard will
contact you, if he has not already done so, to discuss at length
what he has found. Will you print this information?
9.) Why did your long-time manager of research and development,
Rich Wiggins, resign?
Dr. Wiggins left Biocontrol to pursue his own interests that
include the founding of his own optical research instrument
company.
10). Biocontrol has said it's on the verge of submitting another
510K [sic] application to the FDA for marketing clearance of the
Diasensor. How many diabetics were tested in the home for this
application?
Biocontrol is presently compiling data for a submission to the
FDA for marketing clearance. Mr. Fred Cooper's statement was,
"Although there can be no guarantees, we hope to submit the
510(k) in the very near future." To say that we are "on the
verge" is twisting Mr. Cooper's statement.
The number of patients involved in clinical trials is
confidential between the FDA and Biocontrol Technology, along
with other trial details.
11). When do you expect to submit the new 510k [sic]
application?
A submission will be made as soon as possible.
12). Biocontrol issued a press release this summer saying it was
getting ready to market the Diasensor in the Far East. When do
you expect to begin selling the Diasensor in the Far East?
Biocontrol has been researching the Far East market of the device
and will soon announce the results. To do so here would release
information prior to formal release to the shareholders and
public at large.
13). The FDA's Dr. Bruce Burlington testified before Congress
that Biocontrol officials turned down the agency's offer to help
the company with large scale [sic] clinical trials on the
Diasensor. Burlington said the arrangement would have allowed
Biocontrol to recover the costs of its research. Why did
Biocontrol turn down the offer?
To do such trials as the FDA proposed would have involved
submitting a PMA and an IDE which normally take longer for the
review process and which the Company viewed as a step backwards.
Since the FDA had accepted Biocontrol's submission as a 510(k),
the Company felt it should have been processed as a 510(k).
Also, the costs recovered from such a plan would not have put a
dent in the total development monies already spent.
14). Are Biocontrol's Patrick Cooper and Fred Cooper related?
If so, how?
There is no relationship between Dr. Patrick Cooper and Mr. Fred
Cooper.
412/288-1847
[email protected] File
22150
October 31, 1997
VIA FAX NO. 263-0908
Patricia Sabatini
Pittsburgh Post-Gazette
34 Boulevard of the Allies
Pittsburgh, PA 15222
RE: Biocontrol Technology, Inc.
Dear Ms. Sabatini:
This firm represents Biocontrol Technology, Inc. I am
attaching copies of responses submitted by the Company to the
questions which you forwarded to Susan Taylor earlier this week.
In some of the questions which you submitted, you referred
to "internal documents" which you have stated were provided to
you by company insiders. You should be aware that all Biocontrol
employees are subject to confidentiality agreements protecting
the Company's confidential and proprietary information.
Moreover, the Economic Espionage Act of 1996 makes it a criminal
violation for any person to misappropriate a company's trade
secrets, which is broadly defined to include copying without
authorization. The Act further makes it a criminal offense for
any person to receive or possess any such information knowing
that it has been misappropriated.
The Company fully intends to exercise every means available
to it to protect its confidential and proprietary information.
Sincerely,
Thomas J. Miller
